CLINICAL TRIALS PROFILE FOR VEPDEGESTRANT
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All Clinical Trials for VEPDEGESTRANT
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT05909397 ↗ | A Study of ARV-471 (PF-07850327) Plus Palbociclib Versus Letrozole Plus Palbociclib in Participants With Estrogen Receptor Positive, Human Epidermal Growth Factor Negative Advanced Breast Cancer | Recruiting | Arvinas Estrogen Receptor, Inc. | Phase 3 | 2023-06-28 | The purpose of this study is to understand the safety and effects of the study medicine ARV-471 (PF-07850327) given together with palbociclib in advanced breast cancer. In particular, the study will compare the combination of ARV-471 plus palbociclib to standard of care therapy (letrozole plus palbociclib). Both letrozole and palbociclib are medicines already used for treatment of breast cancer. ARV-471 is a new medicine under study. This study is seeking participants who have breast cancer that: - Have a locally advanced or metastatic disease and cannot be fully cured by surgery or radiation therapy. A metastatic disease is when disease has spread to other parts of the body. - Is sensitive to hormonal therapy such as tamoxifen. This is called estrogen receptor positive disease. - Have not received any prior medicine for advanced disease. Example medications include tamoxifen or letrozole or exemestane. The study will have an open-label SLI (study lead-in) before initiation of Phase 3 trial. During SLI, two dose levels of palbociclib in combination with ARV-471 will be explored in parallel. Assignment to the palbociclib dose is by chance. Half of the participant will receive one dose and the other half another palbociclib dose. The purpose of SLI is to determine the recommended Phase 3 dose of palbociclib to be administered in combination with ARV-471. In the Phase 3, half of the participants will take ARV-471 plus palbociclib while the other half will take letrozole plus palbociclib. In both SLI and Phase 3, participants will take the study medicines by mouth, with food, once a day. Participants will take the study medicines until breast cancer increase in size or side effects become too severe. Side effects refer to unwanted reactions to medications. Participants will visit the study clinic about once every 4 weeks. |
| NCT05909397 ↗ | A Study of ARV-471 (PF-07850327) Plus Palbociclib Versus Letrozole Plus Palbociclib in Participants With Estrogen Receptor Positive, Human Epidermal Growth Factor Negative Advanced Breast Cancer | Recruiting | Pfizer | Phase 3 | 2023-06-28 | The purpose of this study is to understand the safety and effects of the study medicine ARV-471 (PF-07850327) given together with palbociclib in advanced breast cancer. In particular, the study will compare the combination of ARV-471 plus palbociclib to standard of care therapy (letrozole plus palbociclib). Both letrozole and palbociclib are medicines already used for treatment of breast cancer. ARV-471 is a new medicine under study. This study is seeking participants who have breast cancer that: - Have a locally advanced or metastatic disease and cannot be fully cured by surgery or radiation therapy. A metastatic disease is when disease has spread to other parts of the body. - Is sensitive to hormonal therapy such as tamoxifen. This is called estrogen receptor positive disease. - Have not received any prior medicine for advanced disease. Example medications include tamoxifen or letrozole or exemestane. The study will have an open-label SLI (study lead-in) before initiation of Phase 3 trial. During SLI, two dose levels of palbociclib in combination with ARV-471 will be explored in parallel. Assignment to the palbociclib dose is by chance. Half of the participant will receive one dose and the other half another palbociclib dose. The purpose of SLI is to determine the recommended Phase 3 dose of palbociclib to be administered in combination with ARV-471. In the Phase 3, half of the participants will take ARV-471 plus palbociclib while the other half will take letrozole plus palbociclib. In both SLI and Phase 3, participants will take the study medicines by mouth, with food, once a day. Participants will take the study medicines until breast cancer increase in size or side effects become too severe. Side effects refer to unwanted reactions to medications. Participants will visit the study clinic about once every 4 weeks. |
| NCT06005688 ↗ | A Study to Understand the Effects of Carbamazepine on How Vepdegestrant is Processed in Healthy Participants | Completed | Arvinas Estrogen Receptor, Inc. | Phase 1 | 2023-08-18 | The purpose of this study is to understand if carbamazepine reacts with vepdegestrant and affects how it is processed in the bodies of healthy participants. This study is seeking participants who: - are male, or female who cannot have children. - are 18 years or older. - are extremely healthy as decided by medical tests. - have a body mass index (BMI) of 16 to 32 kilogram per meter squared. - have a total body weight of more than 45 kilograms (99 pounds). - can understand the study needs and provide a signed document to take part in the study. All participants in this study will receive one dose of vepdegestrant alone by mouth in Period 1. In Period 2, all participants will receive carbamazepine by mouth once a day for 19 days. Participants will also receive one dose of vepdegestrant by mouth. The levels of vepdegestrant in Period 1 will be compared to the levels of vepdegestrant in Period 2 to decide if carbamazepine affects how vepdegestrant is processed differently in healthy adults. The study duration is 27 days and includes two periods. Participants will stay in the clinical research unit through the end of period 2. The participants may be allowed to leave on Day 4 or at the end of Period 1 but must return at the study doctor's call to complete the study. A follow-up visit for each participant takes place at 28 to 35 days after taking the study medicine for the last time. |
| NCT06005688 ↗ | A Study to Understand the Effects of Carbamazepine on How Vepdegestrant is Processed in Healthy Participants | Completed | Pfizer | Phase 1 | 2023-08-18 | The purpose of this study is to understand if carbamazepine reacts with vepdegestrant and affects how it is processed in the bodies of healthy participants. This study is seeking participants who: - are male, or female who cannot have children. - are 18 years or older. - are extremely healthy as decided by medical tests. - have a body mass index (BMI) of 16 to 32 kilogram per meter squared. - have a total body weight of more than 45 kilograms (99 pounds). - can understand the study needs and provide a signed document to take part in the study. All participants in this study will receive one dose of vepdegestrant alone by mouth in Period 1. In Period 2, all participants will receive carbamazepine by mouth once a day for 19 days. Participants will also receive one dose of vepdegestrant by mouth. The levels of vepdegestrant in Period 1 will be compared to the levels of vepdegestrant in Period 2 to decide if carbamazepine affects how vepdegestrant is processed differently in healthy adults. The study duration is 27 days and includes two periods. Participants will stay in the clinical research unit through the end of period 2. The participants may be allowed to leave on Day 4 or at the end of Period 1 but must return at the study doctor's call to complete the study. A follow-up visit for each participant takes place at 28 to 35 days after taking the study medicine for the last time. |
| NCT06125522 ↗ | TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer. (Sub-Study C) | Recruiting | Arvinas Estrogen Receptor, Inc. | Phase 1/Phase 2 | 2024-01-10 | The purpose of this study is to learn about the safety and effects of the study medicine called vepdegestrant. The safety and effects of vepdegestrant will be see when given with other medicines. Vepdegestrant is studied to see if it can be a possible treatment for advanced metastatic breast cancer. This type of cancer would have spread from where it started (breast) to other parts of the body and would be tough to treat. The study is seeking for participants who have breast cancer that: - is hard to treat (advanced) and may have spread to other organs (metastatic). is sensitive to hormonal therapy (it is called estrogen receptor positive). - is no longer responding to treatments taken before starting this study. This study is divided into separate sub-studies. For Sub-Study C: All the participants will receive vepdegestrant and a medicine called samuraciclib. Vepdegestrant and samuraciclib will be taken once in a day by mouth. The medicines will be taken at home. The experience of people receiving the study medicines will be studied. This will help see if the study medicine is safe and effective. Participant will continue to take vepdegestrant and samuraciclib until: - their cancer is no longer responding, or - side effects become too severe. They will have visits at the study clinic about every 4 weeks. |
| NCT06125522 ↗ | TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer. (Sub-Study C) | Recruiting | Carrick Therapeutics Limited | Phase 1/Phase 2 | 2024-01-10 | The purpose of this study is to learn about the safety and effects of the study medicine called vepdegestrant. The safety and effects of vepdegestrant will be see when given with other medicines. Vepdegestrant is studied to see if it can be a possible treatment for advanced metastatic breast cancer. This type of cancer would have spread from where it started (breast) to other parts of the body and would be tough to treat. The study is seeking for participants who have breast cancer that: - is hard to treat (advanced) and may have spread to other organs (metastatic). is sensitive to hormonal therapy (it is called estrogen receptor positive). - is no longer responding to treatments taken before starting this study. This study is divided into separate sub-studies. For Sub-Study C: All the participants will receive vepdegestrant and a medicine called samuraciclib. Vepdegestrant and samuraciclib will be taken once in a day by mouth. The medicines will be taken at home. The experience of people receiving the study medicines will be studied. This will help see if the study medicine is safe and effective. Participant will continue to take vepdegestrant and samuraciclib until: - their cancer is no longer responding, or - side effects become too severe. They will have visits at the study clinic about every 4 weeks. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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